Volt Technical Resources

Senior Regulatory Affairs Specialist

Volt Technical Resources$114K — $122K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or master's Degree or equivalent required.
  • Regulatory experience in pharmaceuticals or diagnostics is essential.
  • Minimum of 4+ years relevant experience required.
  • Post-graduate certification and/or license may be necessary.

Responsibilities

  • Develop programs to ensure products meet safety, legal, and compliance standards.
  • Provide regulatory support for product labeling and marketing material compliance.
  • Prepare documentation for regulatory submissions for new and existing products.
  • Compile materials for submissions, renewals, and maintain current regulatory information.
  • Manage regulatory environment changes to mitigate risks and prevent trade barriers.
  • Respond to product compliance inquiries from customers and authorities.
  • Represent the company in regulatory discussions at multiple levels.

Benefits

  • Health, dental, and vision insurance available based on eligibility.
  • Term life and short-term disability insurance offered.
  • Accidental Death & Dismemberment (AD&D) insurance included.
  • 401(k) retirement plan available for employees.
  • Sick time and other types of paid leaves as required by law.
  • Employee Assistance Program (EAP) provided for support.
Full Job Description
Senior Regulatory Affairs Specialist, you will:
  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
  • Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
  • Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
  • Responds to customers' and/or authorities' requests/inquiries dealing with regulations and product compliance.
  • Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

This is a full-time- contract opportunity.

The Ideal Candidate will have:
  • Bachelor's or master's Degree or equivalent.
  • Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
  • Typically, at least 4+ years relevant experience for entry into this level.
  • Post-graduate certification and/or license may be required.


PAY RANGE AND BENEFITS:

Pay Range*: $55 - $59 per hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

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